AUSTRALIA

AS5074

Australia is using the AS5074, which is based on the ISO4074 with some additional requirements. Also your product will have to be registered with the Australian TGA which comes with a yearly fee.

kitemark

united kingdom

BSI in the UK is owner of the Kitemark logo. Many condom brands in UK still use this quality logo on their packaging but it is not legally required. Bizzy Diamond is NOT able to supply condoms with the Kitemark on the pack.

Medical devices

south america and CARIBBEAN

FDA

Most South American and Caribbean countries follow the FDA rules for medical devices. But rules may differ per country.

Switzerland

OK logo

Switzerland has its own quality system. Condoms have to comply to the CE standard but also need the Swiss OK logo on the pack. For the OK logo every batch has to be separately tested.

ISO4074 standard

Condoms are a Medical Device Class IIb. Worldwide CE condoms have to comply with the ISO4074 standard. You can recognize a CE certified product by the CE logo on the pack. Every country has local laws regarding medical devices. Therefore we will always ask in which country you are going to sell your products before we can make the right price offer.

Bizzy Diamond is a member of the standardization committee of the ISO4074 standard.

Commercial quality logo's

N/f logo

france

LNE in France is owner of the NF logo. Many condom brands in France still use this quality logo on their packaging but it is not legally required. Bizzy Diamond is able to supply condoms with the NF test procedure and the NF logo on the pack.

notified bodies

quality logo's

Some notified bodies have started their own quality logo that can be used on a product to give consumers extra quality assurance. In the past this was a good idea. But with the start of the new ISO4074 standard in 2002 the quality of condoms has tremendously improved, making the use of these additional quality logos almost obsolete.

Additional quality logos are a marketing tool and are never a legal requirement. The extra test cost are very high and make the product more expensive. So the use of these logos on your packaging is always a commercial choice, never a legal requirement.

FDA - countries

CE - countries

Canada

CMDCAS

Canada has its own quality system which is called CMDCAS. Bizzy Diamond is not yet CMDCAS certified and is therefore not yet able to supply to Canada.

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Medical devices

Africa

condoms

Every country has their own quality system for medical devices.

USA

FDA

For the USA condoms have to comply with the rules of the FDA. The FDA has specific rules regarding the text and warnings on the packs, leaflet and condom foil. Also the importer of medical devices needs a registration with the FDA. Bizzy Diamond BV is registered with the FDA and allowed to distribute condoms in the USA.

Europe

condoms

In Europe condoms have to comply with the European Council Directive 93/42/EEC for Medical Devices. Every country has to incorporate this Directive into their local law. In order to facilitate free distribution in Europe, countries are not allowed to make substantial changes to this directive. But there are small differences per country in Europe. Some countries need registration with the government and some countries charge tax on the distribution of medical devices.